Label: DIMETAPP COUGH AND ALLERGY- diphenhydramine hydrochloride tablet, chewable

  • NDC Code(s): 69536-370-24
  • Packager: Foundation Consumer Healthcare
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 15, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Diphenhydramine HCl 12.5 mg

    Active ingredients (in each chewable tablet)Purposes
    Diphenhydramine HCl 12.5 mgAntihistamine/Cough suppresant

  • Uses

    • temporarily relieves:
      • cough
      • runny nose
      • sneezing
      • itching of the nose or throat
      • itchy, watery eyes due to hay fever
    • temporarily alleviates the intensity of coughing
  • WARNINGS

    Warnings

    Do not use

    • to sedate a child or make a child sleepy
    • with any other product containing diphenhydramine, even one used on skin

    Ask a doctor before use if you have

    • glaucoma
    • trouble urinating due to enlarged prostate gland
    • cough that occurs with too much phlegm (mucus)
    • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers

    When using this product

    • may cause marked drowsiness
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a vehicle or operating machinery
    • excitability may occur, expecially in children

    Stop use and ask a doctor if

    cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

    If pregnant or breast-feeding

    ask a health professional before use.

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    • chew or crush tablets completely before swallowing, do not swallow tablets whole
    • do not take more than 6 doses in 24 hours

    agedose
    adults and children 12 years and overtake 2 tablets every 4 hours not to exceed 12 tablets in 24 hours
    children 6 to under 12 yearstake 1 tablet every 4 hours not to exceed 6 tablets in 24 hours
    children under 6 yearsdo not use

  • Other information

    • store at 20-25°C (68-77°​F)
    • avoid high humidity
  • Inactive ingredients

    D&C red no.27 aluminum lake, D&C red no.30 aluminum lake, dextrates hydrated, ethylcellulose, FD&C blue no.1 aluminum lake, flavor, hydroxypropyl cellulose, magnesium stearate, mannitol, modified corn starch, stearic acid, sucralose, sucrose

  • Questions or comments?

    Call 1-888-594-0828weekdays 9 AM to 5PM EST

  • SPL UNCLASSIFIED SECTION

    Distributed by:

    Foundation Consumer Healthcare, LLC

    Pittsburgh, PA 15212

  • PRINCIPAL DISPLAY PANEL - 24 ct Carton

    CHILDREN'S

    Dimetapp

    DIPHENHYDRAMINE HCl, 12.5 mg

    (Antihistamine/Cough Suppressant)

    GREAT CHEWABLE TASTE

    Cough & Allergy

    Relieves + comforts:

    • Cough
    • Itchy throat
    • Sneezing
    • Runny nose

    6+ years

    24 CHEWABLE TABLETS

    Grape-Flavored

    Dimetapp - 24ct Carton

  • INGREDIENTS AND APPEARANCE
    DIMETAPP  COUGH AND ALLERGY
    diphenhydramine hydrochloride tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69536-370
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SUCROSE (UNII: C151H8M554)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
    DEXTRATES (UNII: G263MI44RU)  
    ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    MANNITOL (UNII: 3OWL53L36A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorpurpleScoreno score
    ShapeROUNDSize12mm
    FlavorGRAPEImprint Code DT
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69536-370-244 in 1 CARTON04/15/2024
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01204/15/2024
    Labeler - Foundation Consumer Healthcare (079675882)
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